Nerve cuff deployment devices

ABSTRACT

Nerve cuff deployment apparatuses and methods of using them to deliver a nerve cuff electrode to a target nerve trunk.

CROSS REFERENCE TO RELATED APPLICATIONS

This patent claims priority to U.S. provisional patent application No.62/598,369, titled (“NERVE CUFF DEPLOYMENT DEVICES”) filed on Dec. 13,2017.

This patent may also be related to pending U.S. patent application Ser.No. 15/510,824, filed on Mar. 14, 2017, and herein incorporated byreference in its entirety.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference in their entirety to the sameextent as if each individual publication or patent application wasspecifically and individually indicated to be incorporated by reference.

FIELD

The inventions described herein relate to the field of implantableneurostimulators.

BACKGROUND

Nerve cuffs (e.g., nerve cuff electrodes) may be used to apply energy toa nerve. For example, a nerve cuff electrode may have a plurality ofsegmented platinum contacts connected by at least one wire made ofdurable and biocompatible conductive material fashioned in a helicalconfiguration. The nerve cuff electrode may include a plurality ofconductive nerve contact segments, with the segments having an innersurface contacting a nerve trunk and an outer surface not contacting thenerve trunk; at least a single wire of a conductive biocompatiblematerial operatively connecting the plurality of conductive nervecontact segments thus forming a segmented strip, the wire configured ashelical portions separated by non-helical portions where the non-helicalportions are secured to the surface of the conductive nerve contactsegments not contacting the nerve trunk; and a conductive lead capableof operatively connecting a waveform generator to at least one of theplurality of nerve contact segments. FIGS. 1-3D illustrate an example ofsuch a nerve cuff electrode.

For example, the nerve cuffs described herein may be applied torelatively large nerve, i.e., a nerve with a diameter exceeding about 3mm and up to 12 mm. The nerve cuff may include a self-curling sheet ofnon-conductive material that includes a first layer, which ispre-tensioned, and a second layer, which is not pre-tensioned. The twolayers are configured to form a cuff containing or holding strips ofconducive material there between. The device may have one, two, three,four or more segmented strips of a conductive material that are disposedadjacent, but not transverse, to one longitudinally extending edge ofthe self-curling sheet, each of these strips of conductive material maybe connected to an electrically conductive lead. The nerve cuff maycontain one strip of a conductive material, termed a monopolarconfiguration, or at least two segmented strips, connected by anelectrically conductive lead, of a conductive material, termed a bipolarconfiguration. The nerve cuff may contain three segmented strips,connected by an electrically conductive lead, of a conductive material,termed a tripolar configuration, or at least four segmented strips,connected by an electrically conductive lead, of a conductive material.Multiple apertures, typically circular but not necessarily so limited inshape, may be disposed at periodic intervals of the innernerve-contacting surface along the curling length of one of the twonon-conductive sheets or layers of the self-curling sheet/cuff. This mayprovide contact to the nerve by exposing and providing continuousmultiple conductive contact points. The exposure may be at any intervalthat exposes as much of the conductive material as possible ordesirable, and exceeds the contact surface area of conventionalelectrodes. Each of the first or top non-conductive sheet or layer andthe second or bottom non-conductive sheet or layer may still retain andcontain the conductive material therebetween, i.e., sandwiched insidethe sheets or layers, so that the conductive material is in factretained and does not pop out or come out while providing efficientcurrent delivery. The non-conductive material may be silicone, theelectrically conductive lead may be stainless steel, and the conductivematerial may be platinum. Other materials for each of the non-conductivematerial, the electrically conductive lead or wire, and the conductivematerial are known in the art. In use, the device may be operativelyconnected, e.g., by an external lead or wire, to a waveform generatorthat provides the regulated waveform.

The wire helical portions may be arranged along the wire length betweenthe conductive nerve contact segments, and the wire non-helical portionsmay be secured to the conductive nerve contact segments by a pluralityof spot welds. The wire helical portions may be embedded in anon-conductive material. The helical portions may be separated bynon-helical portions that connect the conductive nerve contact segments.A second wire may operatively connect the plurality of nerve contactsegments, with the second wire generally parallel with the first wire.The conductive nerve contact segments may be platinum, the wires may bestainless steel, and the non-conductive material may be silicone.

For example, FIG. 1 illustrates an implantable system including a nervecuff 101, a lead 103 connecting the nerve cuff to a controller (e.g.,waveform generator, control circuitry, power source, communicationscircuitry and/or antenna, etc.) 105. Systems including a nerve cuff suchas those described herein, including those shown in FIGS. 1-3D, may beused to apply a high frequency nerve block to acutely treat pain, eitheracute pain or chronic pain (more than 6 months in duration), in humansby blocking nerve conduction on an action potential. Acute treatment mayrefer to on-demand treatment with substantially immediate pain reliefeffect. The nerve cuff may be applied onto a moderate and relativelylarge diameter nerves such as the sciatic nerve. One therapy involvesreversibly blocking peripheral nerves by applying high frequencyalternating current directly on a nerve trunk. Specifically, a currentranging from 5 kHz to 50 kHz may be applied; this may be referred to asa high frequency stimulation, compared to a current of less than 1 kHzapplied in the conventional electrical stimulation described above.Efficacy of the high frequency alternating current therapy in acutenon-human animal experiments (frog, cat) has been reported. U.S. Pat.Nos. 7,389,145 and 8,060,208 describe in general this electricalstimulation technology.

The nerve cuffs described herein may encircle a particular segment of atargeted peripheral nerve, e.g., a sciatic nerve, a tibial nerve. Usinga patient-implanted electrode connected to an electrical waveformgenerator, an electrical waveform may be applied for a time interval,e.g., 10 min, sufficient to effect substantially immediate patient painrelief, e.g., within 10 min, and an extended period of pain relief up toseveral hours. The current may range, for example, from 4 mApp to 26mApp. In general, electrical nerve block or activation in patients forpain management or other conditions may require a direct interfacingdevice with peripheral nerves in the form of a cuff wrapping around anerve trunk. For example, U.S. Pat. No. 8,731,676 discloses a bipolarnerve cuff electrode with two continuous platinum strips embedded in asilicone substrate used to wrap around a nerve trunk. However, breakageof the platinum strips was found where a larger nerve trunk and/orcertain anatomical characteristics (such as short stumps in above-kneeamputees) were encountered. Inspections of explanted electrodes revealedthat the platinum strips situated around the nerve trunk werewrinkled/creased or broken along their length due to repeated bendingwhen the nerve trunk was compressed and flattened during dailyactivities. Platinum has a low mechanical strength despite its superiorbiocompatibility and electrical characteristics for charge delivery,thus, it may be beneficial to use multiple segmented platinum contacts,each segment connected with wires made of a durable and biocompatibleconductive material, e.g., stainless steel (SS). The total surface areaof all of the platinum contacts may be equivalent to that of acontinuous strip by increasing the width to compensate for the gapsbetween the contacts. The configuration of the wire interconnection mayestablish the durability and flexibility of the cuff electrode. Forexample, a 7-strand of 316LVM wire may be wound into a helix. A gap maybe created along the helix wherever it overlaps with a platinum contact.Conventional spot welding may be used for connecting the wire to theplatinum contact. Two wire helices lying in parallel may be employed toprovide redundancy. The helices may be entirely embedded in the siliconesheeting and only the outer side of the platinum contacts was exposed tothe surface of the nerve trunk.

In use, the application of 10 kHz alternating current generated by acustom generator via a custom implanted nerve electrode maysignificantly reduce pain in the majority of patients treated. Forexample, an implantable electrode operatively connected to an externalor implanted waveform generator may be used. The electrode may be aspiral cuff electrode similar to that described in U.S. Pat. No.4,602,624. The electrode may be implanted in a human mammal on a desiredperipheral nerve trunk proximal to the pain source (e.g., a neuroma),such that the cuff encircled the desired peripheral nerve in which theaction potential was to be blocked. The cuff inner diameter may rangefrom about 5 mm to about 12 mm. The sciatic nerve is known to have arelatively large nerve trunk; the diameter of the proximal part of thesciatic nerve in a human adult is about 12 mm. In one embodiment, theapparatus and method was used on the sciatic nerve to treat limb pain inabove knee amputees. In one embodiment, the apparatus and method wasused on the tibial nerve to treat limb pain in below knee amputees.

For example, FIG. 2A illustrates the use of a system including a cuffelectrode applied to the sciatic nerve of an amputee patient. In thisexample, the amputee 107 has been implanted with a nerve cuff 101 aroundthe sciatic nerve (nerve trunk), and is connected, via a lead 103, tothe controller including the waveform generator 105. This procedure maybe done, for example, by first dissecting to expose the nerve in an openprocedure, then wrapping the nerve with the flexible (self-closing)cuff. Once implanted the controller/waveform generator may be placed ina pocket in the anterorlateral abdominal wall, and a tunneling electrodecable may be positioned along the midaxilalary line (includingtransversely across the abdomen) to connect the controller/waveformgenerator to the nerve cuff electrode. Once the impedance of the nervecuff is checked (e.g., by the controller) the incisions may be closed.The incision for implanting the nerve cuff is typically larger thanabout 1.5 inches (e.g., between 1.5 and 3 inches), so that sufficientvisualization and access may be achieved.

Any reduction in the size of this access incision would be highlydesirable. However, to date, because of the difficulty in accessing thenerve trunk of the amputee, only open procedures have been used.Described herein are methods and apparatuses (including systems anddevices, which may specifically include access tools) for minimallyinvasively attaching a nerve cuff, and specifically nerve cuffs such asthose described, e.g., in U.S. patent application no. US20170246453A1.

SUMMARY OF THE DISCLOSURE

Described herein is a deployment device to introduce a nerve cuffelectrode via minimal surgical incision, including a cannulaaccommodating, e.g., a 13 mm diameter. The nerve cuff electrode may bedeployed via an apparatus such as an introducer tool which encapsulatesthe electrode (e.g., in some variations via a two-part compartment) andprovides support for visualizing and positioning the nerve cuff,protecting the nerve cuff electrode, so that it can be implanted in thedesired location in a minimally invasive manner.

In some variations, the introducer capsule is delivered and pushedthrough the cannula (e.g., trocar), once the nerve target is identifiedand exposed via the cannula. In any of these variations, endoscopicvisualization may be used as part of the deployment; the delivery toolmay couple with or integrate with an endoscope, or may be usedseparately from the endoscope. In some variations, the delivery tool maythen be detached; for example, in variations including a two-partcapsule, the capsule may be detached, and the electrode remains may beimplanted near the target nerve site; the delivery tool (e.g., capsule)may then be removed from the cannula. The electrode may be unrolled viaforceps, placed around the targeted nerve and sutured closed via twosuture loops.

For example, described herein are methods of minimally-invasivelyattaching a nerve cuff electrode to a patient's nerve (e.g., nerveroot). Any of these methods may include: minimally invasively insertinga cannula (which may be part of a trocar) into the patient's body (e.g.,tissue) to a nerve root region; inserting a nerve cuff deployment toolinto the cannula, wherein the nerve cuff electrode is attached at adistal end of an elongated body of the nerve cuff deployment tool,further wherein the elongated body of the nerve cuff deployment tool hasa column strength sufficient to resist buckling at compressive forces ofat least a predetermined amount (e.g., 2 N, 5 N, 10 N, 15 N, 20 N, 25 N,30 N, etc.); advancing the nerve cuff deployment tool distally throughthe cannula into the nerve root region; and disengaging the nerve cufffrom the nerve cuff deployment tool and coupling the nerve cuff to thepatient's nerve root.

Any of these methods may also include visualizing the nerve root region.For example any of these methods may include inserting a visualizationtool into the nerve root region and visualizing the nerve root region.The visualization tool (e.g., a scope) may be separate from the cannula,or it may be combined with/coupled to the cannula. For example, thevisualization tool may include a cannula and may visualize the distalend of the cannula, e.g., near the nerve root region. The scope mayinclude illumination. The scope may include a camera.

The cannula may be inserted as part of a trocar. For example, a trocarhaving a cutting portion (e.g., an obturator) and a cannula may alsoinclude a seal and may be minimally invasively inserted into the body aspart of any of these methods. For example, minimally invasivelyinserting the cannula may include inserting a trocar through thepatient's tissue to the nerve region, wherein the cannula forms a partof the trocar.

In general, the nerve root region includes a region around the nerveroot onto which the nerve cuff electrode is to be positioned. The nerveroot region may be proximal to neuroma (e.g., in an amputated region)and may include the nerve root and any surrounding tissues;alternatively or additionally the surrounding tissues may be removed(e.g., through the cannula) or retracted to create a clearing forinsertion of the nerve cuff electrode.

Any of these methods may include removably attaching the nerve cuffelectrode to the distal end of the elongated body of the nerve cuffdeployment tool. For example, the nerve cuff electrode may be heldwithin a chamber (e.g., capsule) of the nerve cuff deployment tool.Alternatively or additionally, the nerve cuff deployment tool may beconnected by a clip, clamp, etc. to the nerve cuff electrode. The nervecuff deployment tool may be configured to attach to a predeterminedportion of the nerve cuff electrode; alternatively, the nerve cuffdeployment tool may be configured to connected and hold to any region ofthe nerve cuff electrode. In some variations the nerve cuff deploymenttool includes a nerve cuff engagement region that is configured toremovably attach to the nerve cuff electrode. Examples of nerve cuffattachment or engagement regions are described below.

Any of the methods of operation described herein may include removablyattaching the nerve cuff to the distal end of the nerve cuff deploymenttool. This may include least partially enclosing the nerve cuff within achamber of the nerve cuff deployment tool (e.g., within a sleeve,opening, cup, chamber, etc. of the nerve cuff deployment tool distalend, forming part of the nerve cuff engagement region. Alternatively,removably attaching the nerve cuff may comprise fully enclosing thenerve cuff, e.g., within a capsule region at a distal end of the nervecuff deployment tool.

Inserting the nerve cuff deployment tool may include inserting the nervecuff deployment tool with the nerve cuff attached wherein the nerve cuffis a self-rolling nerve cuff electrode. Self-rolling nerve cuffs asdescribed, for example, in U.S. patent application Ser. No. 15/510824,filed on Mar. 14, 2017, herein incorporated by reference in itsentirety. The nerve cuff electrode may be held in a constrained (e.g.,collapsed, constricted, etc.) configuration by the nerve cuff deploymenttool.

The elongated body of the nerve cuff deployment tool may be flexible orrigid. In some variations, the nerve cuff deployment tool has a flexibleelongated body (which still maintains sufficient column strength asindicated above), so as to navigate a bent or curved cannula fordelivery.

Advancing the nerve cuff deployment tool distally through the cannulainto the nerve root region may include positioning a distal end of thenerve cuff deployment tool adjacent to the nerve root within the nerveroot region. For example, the distal end of the cannula may bepositioned immediately adjacent to the nerve (e.g., within about 1 mm)or closely adjacent (e.g., within about 10 mm).

Disengaging the nerve cuff electrode from the nerve cuff deployment toolmay include activating a detachment mechanism at the proximal end of thenerve cuff deployment tool. In some variations the nerve cuff electrodeis disengaged by separating or opening two parts (e.g., halves) of acapsule to release the nerve cuff electrode; this may be done byproximally manipulating the nerve cuff deployment tool to separate thetwo portions forming the capsule, releasing the nerve cuff electrode andremoving the portion of the nerve cuff deployment tool forming thecapsule back into the catheter. For example, disengaging the nerve cufffrom the nerve cuff deployment tool may include separating two halves ofa nerve cuff capsule at the distal end of the nerve cuff deploymenttool. In some variations a separate pusher is included having a distalend configured to apply distal force to the nerve cuff electrode. Thus,any of these methods may include pushing or holding the nerve cuffelectrode using the pusher to separate or disengage the nerve cuffelectrode from the rest of the nerve cuff deployment tool.

Either before, during or after disengaging the nerve cuff electrode fromthe nerve cuff deployment tool, the nerve cuff may be wrapped (e.g.,rolled) around the nerve. For example, in some variations, the nervecuff electrode may be wrapped around the nerve root when released fromthe nerve cuff deployment tool. The nerve cuff electrode may be held inan inverted configuration within the nerve cuff deployment tool, sothat, when released from the nerve cuff deployment tool, it is biased towrap itself around the nerve root; thus, the nerve cuff deployment toolmay position the nerve cuff sufficiently near or adjacent to the nerveroot so that it may automatically wrap itself around the nerve root.Alternatively or additionally, the nerve cuff electrode may bemanipulated by, e.g., a laparoscopic or other tool (e.g., forceps, etc.)to position or wrap around the nerve root. For example, any of thesemethods may include extending one or more manipulators (e.g., pairs ofmanipulators) through the cannula to wrap the nerve cuff around thenerve root.

For example, a method of minimally-invasively attaching a nerve cuffelectrode to a patient's nerve root may include: minimally invasivelyinserting a cannula the patient's tissue to a nerve root region;inserting a nerve cuff deployment tool into the cannula, wherein thenerve cuff electrode comprises a self-curling nerve cuff electrode thatis removably attached at a distal end of an elongated body of the nervecuff deployment tool, further wherein the elongated body of the nervecuff deployment tool has a column strength sufficient to resist bucklingat compressive forces of at least 10 N; advancing the nerve cuffdeployment tool distally through the cannula into the nerve root region;and disengaging the nerve cuff from the nerve cuff deployment tool andwrapping the nerve cuff to the patient's nerve root.

In general, a nerve cuff deployment apparatus for minimally invasivelyattaching a nerve cuff electrode to a patient's nerve root may include:an elongated body having a column strength sufficient to resist bucklingat compressive forces of at least some predetermined amount of force(e.g., 2 N, 3 N, 4 N, 5 N, 6 N, 7 N, 8 N, 9 N, 10 N, 12 N, 15 N, 20 N,25 N, 30 N, etc.); and a nerve cuff engagement region at a distal end ofelongated body, configured to releasably secure to a nerve cuffelectrode.

Any of these systems may include the nerve cuff electrode as part of thesystem, which may be pre-loaded. For example, any of these systems mayinclude a self-curling nerve cuff electrode, as described herein. Thus,the system may include a self-curling nerve cuff releasably coupled tothe nerve cuff engagement region.

The elongated body may be flexible. In some variation, the elongatedbody is rigid.

In some variations the apparatus is configured to form an enclosure tohold the nerve cuff electrode. For example, the elongated body mayinclude a first half and a second half, wherein the nerve cuffengagement region comprises a first capsule portion at the distal end ofthe first half and a second capsule portion at the distal end of thesecond half, wherein the first and second capsule portions areconfigured to couple to form a capsule to enclose and protect the nervecuff electrode.

In some variation, the nerve cuff engagement region includes aflared-open distal-facing region chamber configured to at leastpartially enclose the nerve cuff electrode. Alternatively oradditionally, the nerve cuff engagement region may include a hook orfork configured to releasably engage with the nerve cuff electrode. Thenerve cuff engagement region may hold the expandable (curling) wings ofthe nerve cuff electrode or to the base of the nerve cuff electrode,e.g., where the wire(s) extending from the nerve cuff electrode extendproximally. In some variations, the nerve cuff engagement regioncomprises a rounded distal end configured to engage with the nerve cuffelectrode. The rounded distal end may be configured to support againstthe nerve cuff electrode without damaging the nerve cuff electrode,e.g., by pushing against it. In some variations nerve cuff engagementregion includes a passage for holding the lead extending from the nervecuff.

As mentioned, any of these apparatuses may include a pusher (e.g., anerve cuff pusher) extending adjacent to the elongated body and having adistal end configured to apply distal force to the nerve cuff electrode.The pusher may extend within the elongated body of the nerve cuffdeployment apparatus. The distal-facing end of the pusher (the distalend) may be configured to engage with the nerve cuff electrode. Forexample, the distal-facing end of the pusher may include a forked distalend that is configured to engage with the nerve cuff electrode.

In any of these variations, the nerve cuff deployment apparatus mayinclude a proximal control coupled to the elongated body configured todisengage the nerve cuff engagement region from the nerve cuffelectrode. The proximal control may include a handle, grip, button,switch, slider, or the like. For example, the proximal control may be ahandle coupled to a slider that allows the apparatus to engage with thepusher, for example, and/or the halves of the elongated body that can be(in some variations) separated to release the nerve cuff electrode.

For example, a nerve cuff deployment apparatus for minimally invasivelyattaching a nerve cuff electrode to a patient's nerve root may include:an elongated body having a column strength sufficient to resist bucklingat compressive forces of at least 10 N, wherein the elongated bodycomprises a first half and a second half, each extending distally toproximally; and a nerve cuff engagement region at a distal end ofelongated body, configured to releasably secure to a nerve cuffelectrode, wherein the nerve cuff engagement region further comprises afirst capsule portion at the distal end of the first half and a secondcapsule portion at the distal end of the second half, wherein the firstand second capsule portions are configured to form a capsule to encloseand protect the nerve cuff electrode.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe claims that follow. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 shows one example of a nerve cuff system (including nerve cuff,lead and implantable controller/waveform generator).

FIG. 2A shows an example of the system of FIG. 1 implanted into apatient.

FIG. 2B schematically illustrates the attachment of and nerve cuff suchas the one shown in FIGS. 1-2A onto a nerve trunk.

FIGS. 3A-3D illustrate application of a self-curling nerve cuff onto amodel of a nerve trunk.

FIGS. 4A-4B illustrate one example of a method for minimally-invasivelyapplying a self-rolling nerve cuff onto a nerve trunk as describedherein. In FIG. 4A, access to the nerve trunk onto which the nerve cuffis to be applied is achieved using a trocar or cannula; a visualizationtool (e.g., an endoscope for endoscopic visualization) is also shownallowing the physician to view the application directly. In FIG. 4B, anerve cuff deployment device (tool) is used to support and protect thenerve cuff (e.g., self-rolling nerve cuff) so that it may be minimallyinvasively delivered to the nerve root and deployed for attachment overthe nerve root.

FIGS. 5A-5G illustrate a method of minimally invasively applying aself-rolling nerve cuff onto a nerve trunk using one variations of anerve trunk deployment tool, in greater detail.

FIGS. 6A and 6B illustrate the nerve cuff deployment tool shown in FIGS.5A-5E. FIG. 6A shows the tool assembled to form a capsule that surroundsand protects the nerve cuff electrode. FIG. 6B shows an exploded view ofthe nerve cuff deployment tool of FIG. 6A, which may be assembled tofully enclose the nerve cuff electrode.

FIGS. 6C and 6D illustrate a nerve cuff deployment tool similar to thatshown in FIG. 6A-6B. In FIG. 6C the nerve cuff deployment tool forms acapsule at the distal end to fully enclose the nerve cuff electrode; apusher extends adjacent to and within the elongated body to apply distalforce to the nerve cuff electrode. FIG. 6D shows an exploded view of thenerve cuff deployment tool of FIG. 6C.

FIGS. 7A1-7A2 show another example of a nerve cuff deployment tool thatincludes a flexible deployment tool having high column strength that maybe releasably attached to the self-curling nerve cuff (as shown in FIG.7A1) and used to push or pull the nerve cuff within a delivery cannulaor trocar. FIG. 7A2 shows the tool unconnected to a nerve cuff.

FIG. 7B shows another example of a flexible deployment tool having ahigh column strength that may be used to push (or in some variations,pull) the self-curling nerve cuff distally through a delivery cannula ortrocar for minimally invasive insertion, as described herein.

FIG. 7C shows another example of a flexible deployment tool having ahigh column strength that may be used to push (or in some variations,pull) the self-curling nerve cuff distally through a delivery cannula ortrocar for minimally invasive insertion, as described herein.

FIGS. 7D1 and 7D2 show another example of a nerve cuff deployment toolthat includes a flexible deployment tool having high column strengththat may be releasably attached to the self-curling nerve cuff (as shownin FIG. 7) and used to push or pull the nerve cuff within a deliverycannula or trocar.

FIGS. 8A-8C illustrate alternative examples of nerve cuffs that may beused with any of the methods and apparatuses described herein. In FIG.8A, the nerve cuff is hinged (e.g., two-part) nerve cuff. FIG. 8B showsthe hinged nerve cuff of FIG. 8A wrapped around a nerve in an end viewand FIG. 8C shows the hinged nerve cuff of FIG. 8A in an externalperspective view on the nerve trunk.

DETAILED DESCRIPTION

In general, described herein are methods and apparatuses, including inparticular tools such as nerve cuff deployment tools and methods ofusing them, for minimally invasively attaching a nerve cuff to a nervetrunk. In particular, described herein are methods and apparatuses fordelivering nerve cuff electrode (particularly self-rolling nerve cuffelectrodes) through an elongated cannula or other elongated, minimallyinvasive channel for deployment at, near or on a nerve root. In general,a nerve cuff deployment apparatus for minimally invasively attaching anerve cuff electrode to a patient's nerve root may have a sufficientcolumn strength (e.g., a column strength sufficient to resist bucklingat compressive forces of at least 2 N, 5 N, 7 N, 8 N, 9 N, 10 N, 15 N,etc.) so that it may support and protect the generally flexible andloose nerve cuff electrode prior to placing it on the nerve root. Thenerve cuff deployment device generally includes a nerve cuff engagementregion at a distal end of elongated body that is configured toreleasably secure to a nerve cuff electrode to be delivered.

As already discussed above, FIGS. 1-2A illustrate current methods forpositioning or placing a nerve cuff onto a nerve root. For example, inan above-the-knee amputee, a nerve cuff may be placed approximately 5 cmproximal to the neuroma on the sciatic nerve; prior to the inventionsdescribed herein, this required a long incision (e.g., 8-10 cm inlength), e.g., between the biceps femoris andsemimembranosus/semitendinosus region of the body. The nerve cuff (e.g.,such as shown in FIG. 2B and 3A-3D) would then be positioned over andaround the exposed nerve root. FIG. 3A-3D illustrates one example ofthis technique. For example, by exposing the nerve, e.g., by dissectingaway material around the nerve, including in some cases cauterizing thetissue around the nerve, the nerve cuff electrode 303 may be pulled,e.g., by use of forceps 305 under and around the nerve. The cuff may beinitially bathed in an antibiotic solution. Forceps (e.g., right angleforceps) may be used to gently pull the cuff underneath the nerve (FIG.3B), and the cuff may be wrapped around the nerve, as shown in FIGS.3C-3D. The electrode cable runs superiorly away from the cuff (e.g.,distally).

Although any appropriate nerve cuff may be used, in particular, thenerve cuff may be a self-wrapping nerve cuff, such as illustrated inFIG. 2B. In this example, the nerve cuff 203 includes two proud regions205 that each include suture holes through which a suture to secure thetwo regions together around the nerve may be positioned. The proudregion extend up (e.g., 90 degrees) from the curved/curling plane of thearms forming the nerve cuff electrode. The first proud region isseparated from the second proud region by less than the expectedcircumference of the nerve root onto which the nerve cuff is to beapplied (e.g., +/−50% of the average expected circumference, or within50% of the expected circumference), on one side of the wings, so thatone “wing” may wrap against the nerve root and the other wing (with thetwo proud regions) may extend from the other wing and wrap over thefirst wing, as shown.

Described herein are methods of less invasively applying a nerve cuffelectrode onto a nerve root, including methods of minimally invasivelyapplying the nerve cuff electrode that do not require a large incision.For example, FIGS. 4A-4B illustrate a general method of less invasivelyapplying a nerve cuff, including the use of a nerve cuff deployment toolas described herein. In FIG. 4A, a trocar 403 including a cannula) isfirst inserted into the body to the region of the nerve root region 407onto which the nerve cuff electrode is to be positioned. In thisexample, the nerve root region is just proximal to a neuroma 411. Priorto inserting the trocar/cannula, a visualization tool such as anendoscope 409 may be inserted into the body to visualize the nerve rootregion. In this example, the endoscope is a rigid endoscope; anyappropriate endoscope may be used. Once the trocar is used to positionthe cannula with a distal end opening into the nerve root region, thenerve cuff electrode may be inserted through the cannula and onto thenerve root. In general the nerve cuff electrode is loose, and overlyflexible, so that it cannot be easily inserted through a cannula.Instead, as shown in FIG. 4B, a nerve cuff deployment device 415 may beused to deliver the nerve cuff electrode through the cannula and intoposition.

In FIG. 4B, the nerve cuff deployment device 415 includes a two-partelongated body that ends in a pair of halves that form a capsule 413which may hold a nerve cuff electrode 417, a shown. In this example, thenerve cuff deployment device therefore include an elongated region thatcan be pushed to drive the capsule and therefore the nerve cuffelectrode distally through the cannula.

FIGS. 5A-5G illustrate this method in additional detail. For example, inFIG. 5A, the nerve cuff electrode 517 is held within a nerve cuffengagement region forming a capsule 521; the lead coupled to the nervecuff electrode is either also held within the capsule or extendsproximally through the nerve cuff deployment device. In FIG. 5A, thenerve cuff deployment device is already loaded with the nerve cuffelectrode; once the catheter 503 is positioned, the nerve cuffdeployment device may be driven distally (e.g., by pushing on theproximal end 525) and extended out of the distal end of the catheter, asshown in FIGS. 5B-5C. Thereafter, the nerve cuff electrode may bedisengaged from the nerve cuff deployment tool by separating the twohalves 527, 527′ of the nerve cuff capsule; this may be done at thedistal end of the nerve cuff deployment tool, as shown in FIG. 5D. Theseseparated halves may then be withdrawn back into the catheter and/orfully removed, as shown in FIG. 5E. In some variations, an additionalstep of using a tool such as an endoscope manipulator 535 may be used tohelp wrap the nerve cuff electrode around the nerve root (“nerve”) asshown in FIG. 5G. In some variations the nerve cuff electrode may beheld inverted within the capsule, so that the arms of the nerve cuffelectrode are wrapped in the opposite direction. In this case, aself-wrapping nerve cuff may be biased to automatically wrap around thenerve root, or wrap around with assistance, e.g., from a minimallyinvasive manipulator.

FIGS. 6A and 6B illustrate the nerve cuff deployment tool variationsshown in FIGS. 5A-5G, which includes a capsule region that encloses andprotects (and may constrain) a nerve cuff electrode. In FIG. 6A thenerve cuff deployment tool is pre-loaded to include the nerve cuffelectrode. FIG. 6B shows an exploded view in which a left half 603 and aright half 603′ of the nerve cuff engagement region forming the enclosedcapsule is shown. In FIG. 6B, the two halves may be closed over thenerve cuff electrode and either coupled together or held together withinthe cannula. The nerve cuff electrode 617 includes a highly flexiblelead 618 that may also be held within the capsule, or it may be withinthe elongated body of the nerve cuff deployment tool. FIGS. 6C and 6Dillustrate a similar variation of the nerve cuff deployment tool thatalso includes an inner pusher 621. The pusher may be coupled to thenerve cuff electrode (in FIG. 6C-6D, the pusher is shown to include aforked distal end 623 to engage with the rolled nerve cuff electrodewithin the capsule. In this example, the pusher is a high-columnstrength member than can either hold the nerve cuff electrode inposition when disengaging from the nerve cuff deployment tool or maydrive the nerve cuff electrode distally (e.g., towards the nerve root)when deploying.

FIGS. 7A1-7D2 illustrate other variations of nerve cuff deployment toolsthat may be used with any of the methods descried herein. Elements fromany of the nerve cuff deployment tools shown in any of the variationsand embodiments described may be used with any of other variation orembodiment of a nerve cuff deployment tool. For example, a pusher suchas the one shown in FIG. 6C-6D may be used with any of the nerve cuffdeployment tools shown in FIG. 7A1-7D2.

FIG. 7A1 shows a nerve cuff deployment tool 715 releasably coupled to anerve cuff electrode 717. In this example, the nerve cuff deploymenttool has a bifurcated end 716 (e.g., forked or split) that may coupleand engage with the nerve cuff electrode, and particularly the wrappingarms of the nerve cuff electrode. In some variations one or both armsmay be hinged so as to close (e.g., clamp) onto each other to releasablysecure the nerve cuff assembly between them; a control (e.g., handle,etc. on the distal end of the nerve cuff deployment tool may be operatedto release the arms of the nerve cuff deployment tool. FIG. 7A2 shows aperspective view of the nerve cuff deployment tool not coupled to thenerve cuff.

FIG. 7B shows another variation of a nerve cuff deployment tool 719having a distal end that is rounded 720 to apply force to a portion ofthe nerve cuff electrode 717 without damaging it. In this example thenerve cuff deployment tool is a hollow member that receives the leadconnected to the nerve cuff assembly and provide structural support todrive the nerve cuff electrode distally. The lead may be held within thenerve cuff deployment tool in tension, so that the nerve cuff assemblyis secured to the distal end of the nerve cuff deployment tool.

FIG. 7C shows another example of a nerve cuff deployment tool 723 thatincludes a partial capsule that is distally open. The distal-facing endregion may hold (and constrain expansion of) the nerve cuff electrode717 until it is deployed; for example by withdrawing the nerve cuffdeployment tool elongated body 733 proximally while holding a pusher(not shown) in place relative to the patient's body, or advancing itslightly distally.

FIGS. 7D1 and 7D2 show another example of a nerve cuff deployment tool725 in which the nerve cuff engagement region 736 at the distal end ofthe nerve cuff deployment tool is configured to releasably couple withthe nerve cuff electrode 717. This variation is similar to that shown inFIGS. 7A1-7A2, but may extend over the distal side of the nerve cuffelectrode, allowing it to be both pulled and pushed robustly. Thisvariations may also include a release, e.g., at the proximal end, andthe distal end region may be hinged in one or more positions to removethe connection to the nerve cuff electrode. Alternatively, in somevariations a pusher such as that shown in FIG. 6C-6D may be used todisengage the nerve cuff electrode from the nerve cuff deployment tool.

Although in general, the nerve cuff electrodes described herein aresimilar to those shown in FIGS. 2B-3D, any appropriate nerve cuffelectrode may be used. FIGS. 8A-8C illustrate another variation of anerve cuff electrode in which two halve or sides of the nerve cuffelectrode are hinged together and may be coupled over and around a nerveroot. For example, in FIG. 8A, the nerve cuff electrode shows a leftside 803 and a right side 803′ that are joined initially by hinge region805. The electrodes within the nerve cuff electrode may be similar tothose described above, and each half may be connected to a lead 807,807′. FIG. 8B shows the nerve cuff electrode of FIG. 8A extended over anerve, and secured on the opposite side by, e.g., a suture. FIG. 8Cshows the nerve cuff electrode of FIG. 8A in a perspective view over anerve.

Any of the methods (including user interfaces) described herein may beimplemented as software, hardware or firmware, and may be described as anon-transitory computer-readable storage medium storing a set ofinstructions capable of being executed by a processor (e.g., computer,tablet, smartphone, etc.), that when executed by the processor causesthe processor to control perform any of the steps, including but notlimited to: displaying, communicating with the user, analyzing,modifying parameters (including timing, frequency, intensity, etc.),determining, alerting, or the like.

When a feature or element is herein referred to as being “on” anotherfeature or element, it can be directly on the other feature or elementor intervening features and/or elements may also be present. Incontrast, when a feature or element is referred to as being “directlyon” another feature or element, there are no intervening features orelements present. It will also be understood that, when a feature orelement is referred to as being “connected”, “attached” or “coupled” toanother feature or element, it can be directly connected, attached orcoupled to the other feature or element or intervening features orelements may be present. In contrast, when a feature or element isreferred to as being “directly connected”, “directly attached” or“directly coupled” to another feature or element, there are nointervening features or elements present. Although described or shownwith respect to one embodiment, the features and elements so describedor shown can apply to other embodiments. It will also be appreciated bythose of skill in the art that references to a structure or feature thatis disposed “adjacent” another feature may have portions that overlap orunderlie the adjacent feature.

Terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention.For example, as used herein, the singular forms “a”, “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will be further understood that the terms“comprises” and/or “comprising,” when used in this specification,specify the presence of stated features, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, steps, operations, elements, components, and/orgroups thereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items and may beabbreviated as “/”.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if a device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of over and under. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

Although the terms “first” and “second” may be used herein to describevarious features/elements (including steps), these features/elementsshould not be limited by these terms, unless the context indicatesotherwise. These terms may be used to distinguish one feature/elementfrom another feature/element. Thus, a first feature/element discussedbelow could be termed a second feature/element, and similarly, a secondfeature/element discussed below could be termed a first feature/elementwithout departing from the teachings of the present invention.

Throughout this specification and the claims which follow, unless thecontext requires otherwise, the word “comprise”, and variations such as“comprises” and “comprising” means various components can be co-jointlyemployed in the methods and articles (e.g., compositions and apparatusesincluding device and methods). For example, the term “comprising” willbe understood to imply the inclusion of any stated elements or steps butnot the exclusion of any other elements or steps.

In general, any of the apparatuses and methods described herein shouldbe understood to be inclusive, but all or a sub-set of the componentsand/or steps may alternatively be exclusive, and may be expressed as“consisting of” or alternatively “consisting essentially of” the variouscomponents, steps, sub-components or sub-steps.

As used herein in the specification and claims, including as used in theexamples and unless otherwise expressly specified, all numbers may beread as if prefaced by the word “about” or “approximately,” even if theterm does not expressly appear. The phrase “about” or “approximately”may be used when describing magnitude and/or position to indicate thatthe value and/or position described is within a reasonable expectedrange of values and/or positions. For example, a numeric value may havea value that is +/−0.1% of the stated value (or range of values), +/−1%of the stated value (or range of values), +/−2% of the stated value (orrange of values), +/−5% of the stated value (or range of values), +/−10%of the stated value (or range of values), etc. Any numerical valuesgiven herein should also be understood to include about or approximatelythat value, unless the context indicates otherwise. For example, if thevalue “10” is disclosed, then “about 10” is also disclosed. Anynumerical range recited herein is intended to include all sub-rangessubsumed therein. It is also understood that when a value is disclosedthat “less than or equal to” the value, “greater than or equal to thevalue” and possible ranges between values are also disclosed, asappropriately understood by the skilled artisan. For example, if thevalue “X” is disclosed the “less than or equal to X” as well as “greaterthan or equal to X” (e.g., where X is a numerical value) is alsodisclosed. It is also understood that the throughout the application,data is provided in a number of different formats, and that this data,represents endpoints and starting points, and ranges for any combinationof the data points. For example, if a particular data point “10” and aparticular data point “15” are disclosed, it is understood that greaterthan, greater than or equal to, less than, less than or equal to, andequal to 10 and 15 are considered disclosed as well as between 10 and15. It is also understood that each unit between two particular unitsare also disclosed. For example, if 10 and 15 are disclosed, then 11,12, 13, and 14 are also disclosed.

Although various illustrative embodiments are described above, any of anumber of changes may be made to various embodiments without departingfrom the scope of the invention as described by the claims. For example,the order in which various described method steps are performed mayoften be changed in alternative embodiments, and in other alternativeembodiments one or more method steps may be skipped altogether. Optionalfeatures of various device and system embodiments may be included insome embodiments and not in others. Therefore, the foregoing descriptionis provided primarily for exemplary purposes and should not beinterpreted to limit the scope of the invention as it is set forth inthe claims.

The examples and illustrations included herein show, by way ofillustration and not of limitation, specific embodiments in which thesubject matter may be practiced. As mentioned, other embodiments may beutilized and derived there from, such that structural and logicalsubstitutions and changes may be made without departing from the scopeof this disclosure. Such embodiments of the inventive subject matter maybe referred to herein individually or collectively by the term“invention” merely for convenience and without intending to voluntarilylimit the scope of this application to any single invention or inventiveconcept, if more than one is, in fact, disclosed. Thus, althoughspecific embodiments have been illustrated and described herein, anyarrangement calculated to achieve the same purpose may be substitutedfor the specific embodiments shown. This disclosure is intended to coverany and all adaptations or variations of various embodiments.Combinations of the above embodiments, and other embodiments notspecifically described herein, will be apparent to those of skill in theart upon reviewing the above description.

1. A method of minimally-invasively attaching a nerve cuff electrode toa patient's nerve root, the method comprising: minimally invasivelyinserting a cannula into the patient's body to a nerve root region;inserting a nerve cuff deployment tool into the cannula, wherein thenerve cuff electrode is attached at a distal end of an elongated body ofthe nerve cuff deployment tool, further wherein the elongated body ofthe nerve cuff deployment tool has a column strength sufficient toresist buckling at compressive forces of at least 10 N; advancing thenerve cuff deployment tool distally through the cannula into the nerveroot region; and disengaging the nerve cuff from the nerve cuffdeployment tool by separating two halves of a nerve cuff capsule at thedistal end of the nerve cuff deployment tool and coupling the nerve cuffelectrode to the patient's nerve root.
 2. The method of claim 1, furthercomprising inserting a visualization tool into the nerve root region andvisualizing the nerve root region.
 3. The method of claim 1, whereinminimally invasively inserting the cannula comprises inserting a trocarthrough the patient's tissue to the nerve region, wherein the cannulaforms a part of the trocar.
 4. The method of claim 1, further comprisingremovably attaching the nerve cuff electrode to the distal end of theelongated body of the nerve cuff deployment tool.
 5. The method of claim4, wherein removably attaching the nerve cuff electrode comprises atleast partially enclosing the nerve cuff electrode within a chamber ofthe nerve cuff deployment tool.
 6. The method of claim 4, whereinremovably attaching the nerve cuff electrode comprises fully enclosingthe nerve cuff electrode within a capsule region at a distal end of thenerve cuff deployment tool.
 7. The method of claim 1, wherein insertingthe nerve cuff deployment tool comprises inserting the nerve cuffdeployment tool with the nerve cuff electrode attached wherein the nervecuff electrode is a self-rolling nerve cuff electrode.
 8. The method ofclaim 1, wherein inserting the nerve cuff deployment tool comprisesinserting the nerve cuff deployment tool wherein the elongated body ofthe nerve cuff deployment tool is flexible.
 9. The method of claim 1,wherein advancing the nerve cuff deployment tool distally through thecannula into the nerve root region comprises positioning a distal end ofthe nerve cuff deployment tool adjacent to the nerve root within thenerve root region.
 10. The method of claim 1, wherein disengaging thenerve cuff electrode from the nerve cuff deployment tool comprisesactivating a detachment mechanism at the proximal end of the nerve cuffdeployment tool.
 11. (canceled)
 12. The method of claim 1, wherein thenerve cuff electrode forms around the nerve when released from the nervecuff deployment tool.
 13. The method of claim 1, further comprisingextending one or more manipulators through the cannula to wrap the nervecuff electrode around the nerve root.
 14. (canceled)
 15. A nerve cuffdeployment apparatus for minimally invasively attaching a nerve cuffelectrode to a patient's nerve root, the apparatus comprising: anelongated body having a column strength sufficient to resist buckling atcompressive forces of at least 10 N; and a nerve cuff engagement regionat a distal end of elongated body, configured to releasably secure to anerve cuff electrode, wherein the nerve cuff engagement region comprisesa flared-open distal-facing region chamber configured to at leastpartially enclose the nerve cuff electrode.
 16. The system of claim 15,further comprising a self-curling nerve cuff electrode.
 17. The systemof claim 15 further comprising a self-curling nerve cuff electrodereleasably coupled to the nerve cuff engagement region.
 18. The systemof claim 15, wherein the elongated body is flexible.
 19. The system ofclaim 15, wherein the elongated body comprises a first half and a secondhalf, further wherein the nerve cuff engagement region comprises a firstcapsule portion at the distal end of the first half and a second capsuleportion at the distal end of the second half, wherein the first andsecond capsule portions are configured to couple to form a capsule toenclose and protect the nerve cuff electrode.
 20. (canceled)
 21. Thesystem of claim 15, wherein the nerve cuff engagement region comprises ahook or fork configured to releasably engage with the nerve cuffelectrode.
 22. The system of claim 15, wherein the nerve cuff engagementregion comprises a rounded distal end configured to engage with thenerve cuff electrode.
 23. The system of claim 15, further comprising apusher extending adjacent to the elongated body having a distal endconfigured to apply distal force to the nerve cuff electrode.
 24. Thesystem of claim 23, wherein the pusher extends within the elongatedbody.
 25. The system of claim 23, wherein the pusher comprises a forkeddistal end configured to engage with the nerve cuff electrode.
 26. Thesystem of claim 23, further comprising a proximal control coupled to theelongated body configured to disengage the nerve cuff engagement regionfrom the nerve cuff electrode.
 27. A nerve cuff deployment apparatus forminimally invasively attaching a nerve cuff electrode to a patient'snerve root, the apparatus comprising: an elongated body having a columnstrength sufficient to resist buckling at compressive forces of at least10 N, wherein the elongated body comprises a first half and a secondhalf, each extending distally to proximally; and a nerve cuff engagementregion at a distal end of elongated body, configured to releasablysecure to a nerve cuff electrode, wherein the nerve cuff engagementregion further comprises a first capsule portion at the distal end ofthe first half and a second capsule portion at the distal end of thesecond half, wherein the first and second capsule portions areconfigured to form a capsule to enclose and protect the nerve cuffelectrode.